Treatment for Completers of the Study B7A-MC-MBCM

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00266695
First received: December 15, 2005
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

To provide ruboxistaurin treatment to patients who completed the MBCM study, and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of MBCM before beginning MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.


Condition Intervention Phase
Diabetic Retinopathy
Drug: ruboxistaurin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Treatment for Patients Completing Study B7A-MC-MBCM

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Sustained moderate visual loss (SMVL) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vision loss [ Time Frame: time period between end of MBCM and beginning of MBDV ] [ Designated as safety issue: No ]
  • Sustained moderate vision loss (SMVL), long term [ Time Frame: baseline of study MBCM to end of study MBDV ] [ Designated as safety issue: No ]
  • Time to modified sustained moderate vision loss (mSMVL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Visual acuity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Rate of treatment with focal/grid photocoagulation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Rate of treatment with panretinal photocoagulation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: January 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ruboxistaurin
32 mg tablet 1 QD oral up to 2 years
Other Names:
  • LY 333531
  • Arxxant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients that completed visit 15 of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment.

Exclusion Criteria:

  • Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266695

  Show 29 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00266695     History of Changes
Other Study ID Numbers: 10699, B7A-MC-MBDV
Study First Received: December 15, 2005
Last Updated: October 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Retinopathy
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Retinal Diseases
Vascular Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014